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Ds Diluent [en]
EUDAMEDClass A (EU MDR)
Ref 5950MNModel Please see UDI-DIs for details.
Identity
- Trade Name
- DS DILUENT [EN] EUDAMED
- Device Name
- Haematology Reagents EUDAMED
- Model / Reference
- Please see UDI-DIs for details. EUDAMED5950MN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 86818125250916 EUDAMED
- Basic UDI-DI
- 869901528HD00KY EUDAMED
- Direct Marketing DI
- 86818125250916 EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Ds Diluent [en] by Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 869901528HD00KY | Class A | Active |
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Manufacturer
- Manufacturer
- Archem Sağlik Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇
- EUDAMED SRN
- TR-MF-000027166
Sources (1)
- EUDAMED a48400a9-b640-4c1e-a318-03e90745197e 61 fields · synced Oct 6, 2026